China’s provincial government for Hainan Province has two sets of medical devices going through the urgent medical device needs program, but leveraging this program for regulatory approval in China is still no small undertaking. One complication is that any real-world evidence gathered in Hainan might not suffice for nationwide regulatory approval, but patient recruitment is also difficult.

Precision oncology company Genetron Holdings Ltd. will help develop a liquid biopsy-based malignant tumor screening and early detection testing kit based on its mutation capsule technology.

HONG KONG – Technology took the front seat for a second day, at the 2020 KoNECT-MOHW-MFDS International Conference, with a discussion about the South Korean medical devices landscape attracting both criticism and praise.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) said industry stakeholders supported making in vitro diagnostic (IVD) self-tests available for infectious diseases like influenza but self-tests for cancer and genetic testing for health-related purposes should continue to be prohibited from supply.

As biopharma deal values continue to rise above recent years, a growing percentage of the funds are coming through partnerships with companies headquartered in Asia and nearby countries. The $48.5 billion reported so far in 2020, for deals in which at least one party is based in either Asia, Australia or New Zealand, represents 37% of the global deal value.